Q/A and Q/C Definitions Flashcards
Calibrator
AKA standard. Has a known value. Used to set a machine to specific set points, or in the case of a manual method, a standard has a known value and is used to calculate the patient and control result.
Control
Used to make sure that patient results are correct and to validate patient results.
Quantitative test
Will have a range that the result should fall within. The range is well established by a proven reference method. NUMERIC
Assayed: reference range is included in the package insert
Unassayed: do not have a predetermined reference range and it needs to be established in the lab.
Qualitative
May have a negative or positive control
Shelf Life
The time an unopened product is still stable and considered reliable
Accuracy
The closeness of the result to the true value (mean)
Precision
The ability to get reproducible results
Analyte
A constituent of the sample to be measured
Assay
To analyse a sample to determine the amount, activity, or potency of an analyte or substance
Mean
The average of all values added up and divided by the number of values
Range
The difference between the smallest and largest value
Median
The middle of a sorted list of numbers
Lyphilised
Freeze dried (liquid removed)
Bias
The difference between the true value and the value obtained
Shiift
A sudden change in control mean which could mean incorrect patient results
Trend
A gradual increase or decrease in control values
Systematic Error
A trend or shift away from the mean
Random Error
An occasional result that falls outside the range
Standard Deviation
How close the values are in relation to each other, expresses the average deviation from the mean
Coefficient of Variation
The standard deviation expressed as a percentage
Westgard Rules
Rules (6 main) used individually or in combination to evaluate quality of the analytical run
Troubleshooting
All the steps taken to correct a QC problem or find the cause and solution
Carryover
When the end products or substances from one test is transferred to the next test
Beer’s Law
The amount of light of a particular wavelength absorbed by a substance across a constant distance
Sensitivity
The lowest concentration that can be accurately measured by an assay (lower detection limit)
Specificity
How good the assay is at discriminating between the analyte and interfering substances
Delta Check
Comparison of current results on a patient to the previous results
SDI
A measurement of bias
Verification
A process with the aim of establishing the operational limits and performance characteristics of a new method
Validation
The process of checking if the method performs to the claimed specifications in a laboratory
Correlation Coefficient
Shows the relationship between the 2 methods
QA
Policies and procedures that are put in place to ensure accurate results and high standard of customer service is maintained
Retention Times
The length that laboratory related things are kept in the lab
Physiological variation of results
Differences, fluctuation, or changes of factors
Root cause
The fundamental reason for the occurence of a problem
Corrective Action
Identification and documentation of the root cause of the problem.
Investigating thoroughly to ensure no similar problems could occur
Action taken according to the severity of the problem
Preventative Action
Taking pro-active steps to ensure a potential problem does not occur
Risk Analysis
Identify possible risk areas of processes and procedures that could lead to failure
